Phase 2
Completed N=79
Exploratory Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer
Postoperative Stage II/III Colon Cancer
Source: ClinicalTrials.gov NCT02792842 ↗
Enrolled (actual)
79
Serious AEs
12.7%
Results posted
Apr 2024
Primary outcomePrimary: The Cumulative Rates of Participants With NCI-CTCAE Grade 2 or Higher Peripheral Sensory Neuropathy: Up to End of Study Treatment — 11; 11; 18 Participants
Summary
The purpose of this study is to evaluate the efficacy and safety of ART-123 for the prevention of cancer treatment related symptoms in patients with postoperative stage II / III colon cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Cumulative Rates of Participants With NCI-CTCAE Grade 2 or Higher Peripheral Sensory Neuropathy: Up to End of Study Treatment |
11; 11; 18 | — |
| PRIMARY Least-squares (LS) Means of Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 (FACT/GOG-Ntx-12) Version 4.0 Score at Cycle 12 |
32.3; 36.3; 28.9 | — |
| PRIMARY The Discontinuation Rate of Oxaliplatin Due to Oxaliplatin-Induced Peripheral Neuropathy (OIPN) |
6; 4; 9 | — |
Eligibility Criteria
Main Inclusion Criteria:
- Diagnosed with stage II / III colon cancer
- Deemed to have undergone curative A (Cur A) surgery
- Planning to undergo postoperative adjuvant chemotherapy
Main Exclusion Criteria:
- Have a history of hypersensitivity to any of the ingredients in thrombomodulin alfa (recombinant)
- Have any treatment history of systemic chemotherapy (including any drug in the clinical trial stage) or radiotherapy
- With active double cancer
Data sourced from ClinicalTrials.gov (NCT02792842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.